Effect of Music as a Non-Pharmacological Intervention on Dental Anxiety and Physiological Parameters During Root Canal Treatment: A Prospective Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This prospective, randomized, controlled clinical trial aims to evaluate the effect of music on dental anxiety and physiological parameters during root canal treatment. The study hypothesizes that music significantly reduces pulse rates and anxiety scores and improves comfort during the procedure. A total of 100 adults aged 35 to 50 years requiring single-visit root canal treatment, with ASA I or II and willingness to provide written informed consent. Exclusion criteria include hearing impairment, known psychiatric illness, unstable cardiovascular disease, and current use of sedatives and anxiolytics. Participants will be randomly assigned to either a music group, which will listen to relaxing instrumental music with ambient nature sounds through wireless earphones initiated 5 minutes prior to the treatment and continuing throughout, along with standard root canal treatment, or to a control group, which will receive the standard root canal treatment without music exposure. Pulse rate and oxygen saturation will be recorded at three time points: before treatment, during instrumentation, and after treatment. Anxiety scores will be measured before the treatment using a Modified Dental Anxiety Scale (MDAS), and postoperative experience questionnaire will be measured after the treatment using a five-point Likert scale. The primary outcome is the change in pulse rate, and secondary outcomes include anxiety scores, oxygen saturation, and postoperative experience levels. The study expects music to reduce dental anxiety and physiological parameters and improve patient comfort during root canal treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients aged 35–50 years requiring single-visit root canal treatment in permanent teeth.
- •Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
- •Patients able to understand the study protocol and provide written informed consent.
- •Patients willing to comply with the study procedures.
排除标准
- •Patients with hearing impairment or use of hearing aids that may interfere with the audio intervention.
- •Patients currently taking anxiolytic, sedative, antidepressant, or beta-blocker medications that may influence anxiety levels or physiological parameters.
- •Patients with diagnosed psychiatric disorders or cognitive impairment affecting anxiety assessment.
- •Patients with uncontrolled systemic diseases (e.g., uncontrolled hypertension or unstable cardiovascular disease).
- •Patients requiring retreatment, multi-visit endodontic treatment, or surgical endodontic procedures.
- •Patients unwilling to participate.
研究者
Vivek Taduri
Mamata Institute of Dental Sciences
